Clinical outcomes of bivalirudin and heparin in pediatric extracorporeal membrane oxygenation: A systematic review and meta-analysis

Abstract

Managing anticoagulation during pediatric extracorporeal membrane oxygenation (ECMO) remains a persistent clinical challenge due to the narrow margin between life-threatening hemorrhage and thrombotic occlusion. While bivalirudin has gained traction as a promising alternative to unfractionated heparin (UFH) owing to its predictable pharmacokinetics, robust evidence supporting its pediatric efficacy remains limited. This systematic review and meta-analysis compared clinical outcomes between bivalirudin and UFH in pediatric ECMO populations by searching PubMed, Embase, Scopus, Web of Science, Cochrane CENTRAL and CNKI up to April 4, 2026. Twelve studies (including 770 patients) were analyzed using random-effects models. Compared with UFH, bivalirudin may be associated with significantly lower odds of major bleeding (OR 0.20, 95% CI 0.12-0.32), systemic thrombosis (OR 0.42, 95% CI 0.23-0.75), neurologic events (OR 0.47, 95% CI 0.29-0.78), and in-hospital mortality (OR 0.57, 95% CI 0.41-0.79), alongside faster achievement of therapeutic targets. Although ECMO duration was longer with bivalirudin (SMD 0.43, 95% CI 0.11-0.75), no significant differences were observed in circuit thrombosis, on-ECMO mortality, or time within the therapeutic range. Consequently, bivalirudin may provide a safer, more effective anticoagulation strategy than UFH in pediatric ECMO, though prospective multicenter studies and randomized trials are warranted to validate these findings.